Our service

At the beginning of every research project there is planning.

In addition to determining the optimal study design to answer the research question, planning also includes aspects of practical implementation. Especially studies with newborns, infants, children and adolescents have to meet special requirements.

We support you in the question of the design of your research project and work with you to develop a suitable practice-oriented study concept that is tailored to your research question.

Our offer:

Consulting regarding study design under consideration of

If there is clarity about the desired study design, the Swiss Human Research Act (HRA) category for the project can be determined. From this categorization depend the approval and notification requirements, as well as, among other things, the selection of appropriate templates for the preparation of your study protocol and patient information.

We help you with the classification of your research project and support you in the further processes and observance of national as well as international conditions and requirements.

Our offer:

• Consulting on the categorization of the research project
• Regulatory review of the study protocol and patient information
• Support in the submission to ethics committees and Swissmedic
• Assistance in drafting and submitting amendments (subsequent changes to the study protocol)
• Review of safety reports (Annual Safety reports)

Important information can also be found here:

Nützliche Links:

• https://swissethics.ch/
• https://www.swissmedic.ch/swissmedic/de/home.html
• https://clinicaltrials.gov/
• https://www.kofam.ch/de/categoriser

Relevante Gesetze:

Humanforschungsgesetz:

• https://www.fedlex.admin.ch/eli/cc/2013/617/de

Verordnung über klinische Versuche

• https://www.fedlex.admin.ch/eli/cc/2013/643/de

Medizinprodukteverordnung

• https://www.fedlex.admin.ch/eli/cc/2001/520/de

Guideline for Good Clinical Practice ICH GCP E6 (R2)

• https://ichgcp.net/de

In order to be able to optimally accompany a study, it is important to define the conditions. This is usually done with an agreement. If the project partner is a pharmaceutical company, the content of the company's contract is first reviewed within the PFZ and then legally by the legal department of the USB.

The complete financial and administrative process of a study with a pharmaceutical company or an academic sponsor can be handled by the PFZ.

Our offer:

Finance

• Discussion of the planned study implementation
• Examination of feasibility (feasibility)
• Cost calculation according to visits and effort
• Compilation of the total budget
• Budget negotiation with external contractors
• Budget adjustments due to protocol adjustments in the ongoing study
• Data Transfer and Use Agreements (DTUA) / Data Transfers and Processing Agreements (DTPA) / Material Transfer Agreements (MTA)

Controlling

• Financial management of the study with external partners (invoicing on behalf of the Principal Investigator by the PRC)
• Control of incoming and outgoing payments (in cooperation with the financial accounting department UKBB)

Contracts / Agreements

• Define general conditions of the agreement (number of patients, study duration, visits, budget)
• Draw up and conclude agreement
• Checking the content of contracts with pharmaceutical companies (in cooperation with the USB legal department)
• Contract negotiations with external contractual partners
• Draw up agreement on additional services with UKBB departments
• Review contracts by head of research and have signed by medical director and financial director of UKBB

Administration

• Administrative handling of billing by qualified administrative staff of the PRC

Professional support by a specially trained team is very important for the implementation of clinical studies. The high legal requirements of study conduct are ensured by a well-trained team of research nurses and study coordinators at our center.

Our offer:

• Support in the preparation of specific study documents (Case Report Form, Trial Master File, Investigator Site File).
• Preparation of initiation visits in collaboration with the PI and sponsor
• General support and advice to PIs in the planning and execution of study visits
• Screening, education and inclusion of study participants
• Organization and execution of study visits
• Supervision and monitoring of study participants in specific study rooms
• Protocol-compliant collection, processing, storage and shipment of study-specific samples
• Protocol-compliant dispensing and storage of study medications
• Preparation and follow-up of monitor visits
• Carrying out study documentation in the specified databases
• Support during close-out visits
• Supervision of a study from initiation to archiving
• Archiving of study documents
• Proper destruction of residual stocks of study medication
• Hub and networking for all relevant services at UKBB (laboratory, ICT, outpatient clinic, CTU-USB, laboratory USB, hospital pharmacy)
• Contact person for sponsor and monito

Already during project planning, data collection and data acquisition (data management) as well as later data analysis (statistics) should be considered.

1.     statistics/data science

A high data quality enables a well-founded and robust evaluation and reproducible results that are as unbiased as possible. Our qualified data and statistics team will be happy to support you in this regard.

Our offer:

Study design

• Specification of the research question
• Sample size planning
• Selection of the statistical method/ creation of a statistical analysis plan

Study conduct

• Management or participation in data safety and monitoring boards
• Interim statistical analyses
• Analyses for and writing of an annual safety report

Study completion

• Statistical evaluation
• Preparation of the final statistical report

The statistical analyses are performed using the open source software R or STATA.

2.     Data management 

High-quality data management is becoming more and more important due to legal requirements and increasing awareness of quality control and quality assurance in clinical studies. To digitally capture your data, we offer REDCap, a software solution. 

Our offer:

Setting up surveys and questionnaires (CRFs) in the password-controlled web-based application REDCap with the following functions

• Extensive role and rights management
• Support of multi-center studies via data access groups
• Randomization
• Audit trail
• Query management
• Data import/export in different formats
• Creation of study reports
• Support of researchers in setting up simple REDCap databases on their own.

In many research projects, the storage of residual materials from research samples under high quality standards is of great importance.

The Biobank PRC at the UKBB enables researchers to perform biobanking according to individual planning in temperature-monitored freezers as part of their studies. Our biobank has been awarded the VITA label of the Swiss Biobanking Platform (SBP) and meets all regulatory requirements. Quality assurance measures ensure optimal storage of your samples.

Our offer

• Consulting regarding project-related biobanking
• Implementation of project-related biobanking.